Comprehensive Reverse Shoulder Data Collection

• Conditions: Arthropathy of Shoulder Region; Osteoarthritis of the Shoulder; Grossly Deficient Rotator Cuff; Rheumatoid Arthritis Without Humeral Metaphyseal Defects; Post-Traumatic Arthitis
• Interventions: Device: Biomet Comprehensive Reverse Shoulder

• Registration Number: NCT03404778
• Lead Sponsor: Zimmer Biomet

Brief Summary

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

Detailed Description

The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.

This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.

Study Timeline

• Study Start: 2010-03-07
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-12
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
• The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
• The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion Criteria

• Absolute contraindications include infection, sepsis, and osteomyelitis.
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biomet Comprehensive Reverse Shoulder	Biomet Comprehensive Reverse Shoulder	Subjects in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Shoulder System.

Primary Outcome Measures

Name	Time	Method
Pain Score	1 year	Pain Score is assessed for each subject by asking them to indicate their current level of pain based on a 5 level scale, with "None" as the best outcome and "Severe" as the worst. Improvement of pain score at one year from pre-operative levels will be assessed.

Secondary Outcome Measures

Name	Time	Method
Presence of Scapular Notching	3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years	All radiographic images collected during the study are assessed by the Principal Investigator for the presence of scapular notching. The severity of notching will be assessed using the Nerot system, where Grade 0 indicates no notch and Grade 4 indicates the largest-sized defect in the scapula.
Constant Shoulder Score	Pre-operative, 3 months, 6 months, 1 year, 3 years, 5 years, 7 years, 10 years	The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.

Trial Locations

Locations (4)

Acromion LLC; 🇺🇸 Towson, Maryland, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Allina Health System DBA Sports and Orthopaedic Specialists; 🇺🇸 Edina, Minnesota, United States

Joint Implant Surgeons; 🇺🇸 New Albany, Ohio, United States